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- UV1 continues to show a positive safety profile in line with other UV1
studies with similar events observed in the control arm and good
tolerability
- As previously communicated, financial runway secured until Q4 2025 beyond
expected topline results from DOVACC Phase II study in 1H2025
- Within the available resources, the company is also actively developing a
novel technology platform identified during the TET development and will
provide an update before the end of 2024
Oslo, August 5, 2024: Ultimovacs ASA (https://ultimovacs.com/) (“Ultimovacs”)
(OSE ULTI), a clinical-stage biotechnology leader in novel immunotherapeutic
cancer vaccines, today announced the topline results from the Phase II FOCUS
trial (NCT05075122 (https://classic.clinicaltrials.gov/ct2/show/NCT05075122)).
The topline data readout demonstrated that adding UV1 to the standard of care
pembrolizumab did not lead to clinical benefits in progression free survival or
overall survival in those late-stage HNSCC patients, therefore, the study did
not meet its primary and secondary endpoints.
FOCUS is an investigator-initiated randomized Phase II clinical trial sponsored
by Martin-Luther-University Halle-Wittenberg with support from Ultimovacs. It
investigates Ultimovacs’ therapeutic cancer vaccine, UV1, in combination with
pembrolizumab versus pembrolizumab alone, as a first-line treatment in
metastatic patients or a second-line treatment in patients with recurrent PD-L1
positive head and neck squamous cell carcinoma (HNSCC). In this indication,
pembrolizumab is currently considered the standard of care treatment for
patients. The primary endpoint of the study is progression free survival at 6
months. All patients have been followed up for close to 12 months or longer for
PFS, overall survival (OS) and safety.
“We have implemented a broad Phase II clinical development program testing our
cancer vaccine in a range of different indications. Unfortunately, the FOCUS
study did not provide us with the results we had hoped for, and we are
disappointed that UV1 was not able to provide added clinical benefit for these
HNSCC patients,” said Carlos de Sousa, Chief Executive Officer at Ultimovacs.
“Earlier this year we implemented a cash preservation program, enabling us to
extend our runway to the fourth quarter of 2025 beyond the anticipated DOVACC
Phase II topline readout in the first half of next year. Further, the Ultimovacs
team is actively developing a novel technology platform identified during the
TET development and we look forward to providing more details before year-end.”
The FOCUS trial is being conducted at ten sites across Germany and is led by
Principal Investigator Mascha Binder, M.D., Professor of Medical Oncology at the
Faculty of Medicine, University Hospital of Basel. Professor Binder is a
renowned oncology clinician and researcher specialized in the analysis of
immune-oncology treatments and their interaction with tumor tissues.
Head and neck cancer is the seventh most common type of cancer worldwide, and
squamous cell carcinoma (HNSCC) represents about 90 percent of these patients.
HNSCC occurs in the head and neck region, including the throat, mouth, sinuses
and nose. Despite advances in treatment strategies, the prognosis for these
patients is poor.
Jens Bjørheim, Chief Medical Officer at Ultimovacs added, “We are disappointed
that the FOCUS trial did not achieve the desired outcome for patients, which
underscores the complexities of treating metastatic and recurrent head and neck
cancer. This cancer type is particularly aggressive with limited treatment
options and high rates of recurrence. Our broad clinical development program was
designed to identify the best patient populations for UV1 and we are now
focusing our efforts on the upcoming DOVACC data readout in the first half of
next year.”
Ultimovacs is also investigating UV1 in ovarian cancer in the ongoing Phase II
DOVACC trial which evaluates a combination of olaparib and durvalumab +/- UV1
vs. olaparib alone as second-line maintenance treatment for patients with high-
grade BRCA negative ovarian cancer. Topline results are expected in the first
half of 2025 well within the current financial runway which reaches to the
fourth quarter of 2025.
Ultimovacs will host its Q2 2024 webcast on Wednesday, August 21(st), 2024, at
14.00 CEST.
==ENDS==
About FOCUS
The FOCUS trial (First-line metastatic Or recurrent HNSCC/Checkpoint inhibitor
UV1 Study) is an investigator-sponsored, randomized, open label Phase II
clinical trial. The primary objective of this study is to determine the clinical
performance of UV1 vaccination as add on to standard pembrolizumab treatment as
a first-line treatment in metastatic patients or a second-line treatment in
patients with recurrent PD-L1 positive head and neck squamous cell carcinoma.
Professor Mascha Binder is the principal investigator for the trial, which is
sponsored by the Medical Faculty, University of Halle-Wittenberg in Germany. The
first patient in the FOCUS trial was enrolled in August 2021, and patients have
been treated at 10 sites across Germany. The trial is investigating the
tolerability and efficacy addition of UV1 to standard of care treatment with
programmed death receptor-1 (PD 1)-blocking antibody pembrolizumab versus
pembrolizumab monotherapy. The 75 patients indicated for treatment with
pembrolizumab have been randomized 2-to-1 so that 50 patients will receive UV1
and pembrolizumab and 25 patients will receive pembrolizumab alone. The primary
endpoint is PFS rate at 6 months after first administration of study medication.
Secondary endpoints include PFS and OS (overall survival, by Kaplan-Meier
estimate), objective response rate (ORR), duration of response (DOR) and safety,
with minimum 12 months follow-up. As OS is recognized as the determining
efficacy measure in guiding further development in this cancer indication, the
topline results will be disclosed 12 months after enrollment of the last
patient, allowing simultaneous disclosure of both PFS and OS. The FOCUS Phase II
trial is partially supported through an innovation grant of up to NOK 16 million
from the Norwegian Research Council.
About Head and Neck Squamous Cell Carcinoma (HNSCC)
Head and neck cancer is the term used to describe different malignant tumors
that develop in or around the throat, larynx, nose, sinuses, and mouth. Squamous
cell carcinoma represents about 90 percent of head and neck cancer patients.
Overall survival of patients with metastatic or recurrent HNSCC has improved
over the past decade but remains poor overall. Median overall survival is
limited to less than 15 months, with the current standard of care (immune
checkpoint blockade with or without chemotherapy). Many patients with HNSCC are
frail and therefore cannot tolerate chemotherapy, reducing their treatment
options to checkpoint inhibitor. Therefore, the development of effective and
tolerable combination regimens is urgently needed, especially in first-line
therapy.
About Ultimovacs
Ultimovacs is a clinical-stage biotechnology leader in novel immunotherapeutic
cancer vaccines with broad applicability. Ultimovacs’ lead cancer vaccine
candidate, UV1 is directed against human telomerase (hTERT), an antigen that is
present in 85-90% of cancers in all stages of tumor growth. A broad clinical
program, with Phase II trials in five cancer indications enrolling more than
670 patients, aims to demonstrate UV1’s impact in combination with other
immunotherapies in multiple cancer types expressing telomerase and where
patients have unmet medical needs. UV1 is universal, off-the-shelf and easy to
use, and is a patented technology owned by Ultimovacs.
In addition, Ultimovacs’ adjuvant platform, based on the proprietary Tetanus-
Epitope-Targeting (TET) technology, combines tumor-specific antigens and
adjuvant in the same molecule and is in Phase I clinical development.
About UV1
UV1 is a therapeutic cancer vaccine designed to induce a specific T cell
response against telomerase. UV1 consists of long, synthetic peptides,
representing a sequence in the reverse transcriptase subunit of telomerase
(hTERT), shown to induce CD4+ T cells. These CD4+ T cells have the potential to
provide inflammatory signals and T cell support that are believed to be critical
for triggering a strong anti-tumor immune response. Following intradermal
injection, antigen presenting cells (APCs) in the skin are exposed to the
vaccine peptides. These APCs will process the peptides, and present vaccine
epitopes on Human Leukocyte Antigen (HLA) molecules to naïve T cells in the
lymph nodes. Activated vaccine-specific T cells will then enter the circulation
and search for cells displaying their cognate antigen in the context of HLA
molecules.
The UV1 peptides contain several epitopes, shown to be non-restrictive in terms
of (HLA) alleles for presentation. It is therefore not required to perform HLA
pre-screening of patients, which potentially enables broad population
utilization of the vaccine. UV1 is administered over three months as eight
intradermal injections together with the immune-modulator, GM-CSF.
For further information, please see www.ultimovacs.com or contact:
Carlos de Sousa, CEO
Email: carlos.desousa@ultimovacs.com
(https://www.globenewswire.com/Tracker?data=afQ45JsU1VX536GzmPHZgPebx-
aXOA2_qswy_MSq4TZYlSahqT9Txfz8BtpySO-
ZronmxixcvCgTKXDmb7Iz3vyFeJEo0KK8oTHidt2UbiZXzpyZfujhYyyFd5fA2uzw)
Phone: +47 908 92507
Hans Vassgård Eid, CFO
Email: ir@ultimovacs.com
This information is considered to be inside information pursuant to the EU
Market Abuse Regulation and is subject to the disclosure requirements pursuant
to Section 5-12 in the Norwegian Securities Trading Act.
This stock exchange announcement was published by Hans Vassgård Eid, CFO at
Ultimovacs ASA, on August 5, 2024 at 19.10 CEST.
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